Gynecologic DiseaseNCT05509244
Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery
A study testing Acetaminophen and Ibuprofen in people with Gynecologic Disease, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen only and 2) acetaminophen and ibuprofen combination at postoperative pain after laparoscopic gynecologic surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Acetaminophen and Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Sep 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled gynecologic laparoscopic surgery
Who cannot join
- Refusal to be enrolled in the study
- Emergency surgery
- On chronic pain medications
- Psychiatric disorders
- Pregnant, lactating women
- Allergy or contraindication to the medication drugs
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St.Mary's Hospital
Seoul, Seocho-gu, 07651
Young Eun Moon, Md, PhD
About this study
Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen only and 2) acetaminophen and ibuprofen combination at postoperative pain after laparoscopic gynecologic surgery.
Read the detailed description
Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen 1g only and 2) the combination of acetaminophen 1g and ibuprofen 300mg at postoperative pain after laparoscopic gynecologic surgery. Some recovery valuables such as the postoperative pain and opioid requirements will be assessed.
- Conditions
- Gynecologic Disease
- Being tested
- Acetaminophen, Ibuprofen
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
acetaminophen 1g iv dripping at end of surgery
IbuprofenDrug
ibuprofen 300mg iv dripping at end of surgery
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | acetaminophen 1g iv dripping Receives: Drug: Acetaminophen |
| experimental group | Experimental | the combination of acetaminophen 1g and ibuprofen 300mg iv dripping Receives: Drug: Acetaminophen; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
the maximal postoperative pain severity using pain scale (0=no pain; 10=the worst pain)
Measured: during 30 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start9 Sep 2022
- Primary completion24 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Eun Moon, The Catholic University of Korea
- Investigators
- youngeun moon, MD, PhD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509244
- Sponsor's protocol ID
- acetaminophen-ibuprofen
- Status last verified
- Sep 2022
- First submitted
- 17 Aug 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery
- ClinicalTrials.gov ID
- NCT05509244
- Acronym / sponsor ID
- acetaminophen-ibuprofen
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 24 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen only and 2) acetaminophen and ibuprofen combination at postoperative pain after laparoscopic gynecologic surgery.
Detailed description
Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen 1g only and 2) the combination of acetaminophen 1g and ibuprofen 300mg at postoperative pain after laparoscopic gynecologic surgery. Some recovery valuables such as the postoperative pain and opioid requirements will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Acetaminophenacetaminophen 1g iv dripping |
| experimental group | Experimental | Drug: Acetaminophen, Drug: Ibuprofenthe combination of acetaminophen 1g and ibuprofen 300mg iv dripping |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled gynecologic laparoscopic surgery
Key exclusion criteria (6 listed)
- Refusal to be enrolled in the study
- Emergency surgery
- On chronic pain medications
- Psychiatric disorders
- Pregnant, lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophenacetaminophen 1g iv dripping at end of surgery | Drug | control group, experimental group |
| Ibuprofenibuprofen 300mg iv dripping at end of surgery | Drug | experimental group |
Primary outcome
postoperative pain
Time frame: during 30 minutes after surgery
the maximal postoperative pain severity using pain scale (0=no pain; 10=the worst pain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
youngeun moon, MD, PhD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen and Ibuprofen in people with Gynecologic Disease, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact youngeun moon, MD, PhD (822-2258-6163, 0910momo@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: during 30 minutes after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.